Skip to main content
OpenTrials
Completed

NCT Number: NCT03897907

The Effect of Psychologically Informed Education in Adolescents With Patellofemoral Pain

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with anterior knee pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participant/parents. Participants will then complete clinical tests of physical performance, numeric pain rating scale, and a self-report questionnaire of functional ability. Participants will then be randomized into one of two psychosocial intervention groups (psychologically informed education group and a control group). After participants receive their assigned education intervention, the clinical tests of pain and self-reported functional ability will be readministered. Participants with anterior knee pain will then complete follow-up surveys of their psychosocial beliefs, pain and self-reported functional ability through REDcap at immediately post-intervention, 2 weeks, 6 weeks, and 3 months.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome Joint Diseases Musculoskeletal Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital Sports and Ortho Physical Therapy

Columbus, Ohio, 43215, United States

About this study

This study will be a prospective randomized controlled trial design. Participants will complete the randomized intervention immediately after completing baseline testing. Post-intervention testing will also be completed immediately after the randomized intervention. A follow-up REDcap survey will be sent by email to assess function and pain at 2 weeks, 6 weeks and 3 months.

Intervention Psychologically Informed Education Group Psychologically Informed Education Medium There are many ways to provide patient education, but the investigators believe that adolescents will respond well to video education on a tablet. Adolescents are extremely comfortable with this technology, and the video will allow for standardized education among all participants.

Development of Psychologically Informed Education for adolescents with AKP Recommended adult pain science education will be modified using published recommendations for the adolescent population and tailored to anterior knee pain.(Robins, Perron, Heathcote, & Simons, 2016) The education session will teach participants how the body processes nociception and experiences pain, and pain does not mean tissues are being damaged. Additionally the psychologically informed education video will use the framework called the "Common Sense Model of Self-Regulation" which advocates for education to address five cognitive dimensions: (1) identity (the effort to evaluate symptoms and label the illness); (2) cause (the subjectively formulated belief of what is causing the symptoms); (3) time-line (the patient's perception of how long the problem will last); (4) consequences (the patient's predictions of how the illness will affect them in different areas of their life); and (5) controllability (the patient's belief regarding their outcome and personal ability to change it).(Leventhal, Phillips, & Burns, 2016) Control Group Participants in the control education group will watch a video on the iPad equal in length to the psychologically informed education video. The control video will discuss basic anatomy of the knee and provide no psychosocial education or positive reinforcement about their condition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Having patellofemoral pain as defined as: Pain around or behind the patella, which is aggravated by at least one activity that loads the patellofemoral joint during weight bearing on a flexed knee (e.g., squatting, stair ambulation, jogging/running, hopping/jumping)

Exclusion criteria

  • Prior history of patellar dislocation.
  • Suspicion of other diagnosis of the knee by evaluating physical therapist or principal investigator.
  • Other concomitant injury of the leg.
  • Prior history of knee surgery.
  • Red flags present for non-musculoskeletal involvement (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing).
  • Numbness and tingling in any lumbar dermatome.

Treatment and study plan

Psychologically Informed Education Video

Other

The education session will teach participants how the body processes nociception and experiences pain, and pain does not mean tissues are being damaged. Additionally we will use the framework called the "Common Sense Model of Self-Regulation" which advocates for education to address five cognitive dimensions: (1) identity (the effort to evaluate symptoms and label the illness); (2) cause (the subjectively formulated belief of what is causing the symptoms); (3) time-line (the patient's perception of how long the problem will last); (4) consequences (the patient's predictions of how the illness will affect them in different areas of their life); and (5) controllability (the patient's belief regarding their outcome and personal ability to change it)

Anatomy Education Video

Other

Participants in the control group will watch three videos equal in length to the psychologically-informed videos. The control videos will discuss anatomy of the lower extremity, basic instruction in proper lower extremity biomechanics, and simple lower extremity exercises. The control videos will provide no psychologically-informed education or positive reinforcement about the condition.

Primary outcomes

  1. Change in Anterior Knee Pain Scale

    Time frame: Time Frame: Baseline, 2 weeks (12-16 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months

    Assessment of change of the Anterior Knee Pain Scale (AKPS). The AKPS is a self-reported 13 item questionnaire with discrete categories related to various levels of current knee function. Categories within each item are weighted, and responses are summed to provide an overall score of 0-100, with 100 representing no disability. The Anterior Knee Pain Scale is found to be valid and reliable in patients from 12-50 years of age presenting with anterior knee pain with a test-retest reliability of .95 (Watson, 2005). A change of 10 points represent the minimal clinical difference (Crossley, 2004).

Secondary outcomes

  1. Change in Numeric Pain Rating Scale

    Time frame: Time Frame: Baseline, 2 weeks (12-16 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months

    The Numeric Pain rating scale asks the patient their highest pain in the last 24 hours. The Numeric Pain Rating Scale is a 0-10 scale subjectively assessing a patients perceived level of pain. With 0 on the scale = to no pain, and 10 = to the worst pain imaginable. The use of the Numerical Pain Rating Scale for assessing pain has been validated for use in patients with knee pain and has been found to have a minimal detectable change of 1 points.

  2. Change in Fear-Avoidance Beliefs

    Time frame: Time Frame: Baseline, immediately post-intervention, 2 weeks (12-16 days post-evaluation),

    Fear avoidance beliefs as measured by the Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale

  3. Change in Kinesiophobia

    Time frame: Time Frame: Baseline, immediately post-intervention, 2 weeks (12-16 days post-evaluation),

    Change in kinesiophobia beliefs as measure by the Tampa Scale for Kinesiophobia-11 scale

  4. Change in Pain Catastrophizing

    Time frame: Time Frame: Baseline, immediately post-intervention, 2 weeks (12-16 days post-evaluation),

    Change in pain catastrophizing as measured by the pain catastrophizing scale-child version

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2019
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.